Fresenius Kabi, a leading provider of essential medicines and medical technologies, has announced the introduction of a new presentation of Otulfi (ustekinumab-aauz) in a 45 mg/0.5 mL single-dose vial for subcutaneous injection. Otulfi is the FDA-approved biosimilar of Stelara (ustekinumab), and with this addition, Fresenius Kabi now offers all dosage forms and strengths of the reference product, providing physicians greater flexibility and supporting continuous patient treatment. The biosimilar has also received an FDA interchangeability designation, allowing substitution for the reference product according to state pharmacy laws, which can reduce administrative burden for healthcare providers.
Health Technology Insights: GenSight Biologics Gets CUA for GS010/LUMEVOQ in France
Originally approved by the U.S. Food and Drug Administration in September 2024, Otulfi is indicated for adults with moderately to severely active Crohn’s disease and ulcerative colitis, adults and pediatric patients aged six and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, and for those with active psoriatic arthritis. The new single-dose vial supports more flexible dosing, particularly for pediatric patients under 60 kg who require treatment for plaque psoriasis or psoriatic arthritis.
Health Technology Insights: Pulse Biosciences Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Earlier in March, Fresenius Kabi introduced Otulfi in 45 mg/0.5 mL and 90 mg/mL single-dose prefilled syringes for subcutaneous injection as well as a 130 mg/26 mL single-dose vial for intravenous infusion. Dr. Sang-Jin Pak, President of Biopharma at Fresenius Kabi, stated that the new vial expands treatment options for pediatric patients while reinforcing the company’s commitment to improving access to biosimilars. He emphasized that Fresenius Kabi is focused on growing its biosimilar portfolio to ensure patients of all ages can benefit from therapies that meet the FDA’s strict standards for safety and effectiveness.
The FDA granted Otulfi interchangeable biosimilar status in May 2025. This designation allows pharmacies to substitute Otulfi for the reference product Stelara without requiring direct approval from the prescribing healthcare provider, depending on local state regulations. This designation is notable as not all biosimilars are approved for interchangeability and it may help streamline care and reduce administrative workload for providers, while maintaining patient safety and treatment efficacy.
Health Technology Insights: Bristol Myers Squibb Partners with U.S. to Boost Drug Access
To participate in our interviews, please write to our HealthTech Media Room at info@intentamplify.com
